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Drug company (FDA labeler)

Gland Pharma Limited

NDC labeler code: 68083

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

126Prescription medicines
260Products (NDC)
152FDA applications
0Recalls

Prescription medicines

Show the other 86 medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
October 26, 2026ANDA220400 Epinephrine
EPINEPHRINE		Gland
October 15, 2026ANDA221145 Buprenorphine
BUPRENORPHINE HYDROCHLORIDE		Gland
September 30, 2026ANDA220181 Levocarnitine
LEVOCARNITINE		Gland
July 31, 2026ANDA219996 Atropine
ATROPINE SULFATE		Gland
July 28, 2026ANDA214364 Sugammadex
SUGAMMADEX SODIUM		Gland
June 11, 2026ANDA219166 Brimonidine tartrate and timolol maleate
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE		Gland
March 11, 2026ANDA219219 Brimonidine tartrate
BRIMONIDINE TARTRATE		Gland
February 5, 2026ANDA219984 Zoledronic acid
ZOLEDRONIC ACID		Gland
January 6, 2026ANDA219167 Bortezomib
BORTEZOMIB		Gland
December 29, 2025ANDA219237 Epoprostenol
EPOPROSTENOL SODIUM		Gland
November 12, 2025ANDA218200 Leucovorin calcium
LEUCOVORIN CALCIUM		Gland
August 11, 2025ANDA213551 Cangrelor
CANGRELOR		Gland
July 8, 2025ANDA219629 Selenious acid
SELENIOUS ACID		Gland
June 17, 2025ANDA219775 Acetazolamide
ACETAZOLAMIDE SODIUM		Gland
June 3, 2025ANDA216966 Angiotensin II
ANGIOTENSIN ll ACETATE		Gland
June 3, 2025ANDA218144 Epinephrine
EPINEPHRINE		Gland
April 29, 2025ANDA217387 Latanoprostene bunod ophthalmic solution, 0.024%
LATANOPROSTENE BUNOD		Gland
April 2, 2025ANDA219215 Acetaminophen
ACETAMINOPHEN		Gland
March 21, 2025ANDA218140 Vancomycin
VANCOMYCIN HYDROCHLORIDE		Gland
February 24, 2025ANDA217800 Thiamine hydrochloride
THIAMINE HYDROCHLORIDE		Gland
February 6, 2025ANDA219239 Epinephrine
EPINEPHRINE		Gland
January 16, 2025ANDA218211 Ephedrine sulfate
EPHEDRINE SULFATE		Gland
December 18, 2024ANDA218129 Phenylephrine
PHENYLEPHRINE HYDROCHLORIDE		Gland
December 10, 2024ANDA217386 Phytonadione
PHYTONADIONE		Gland
November 26, 2024ANDA218257 Latanoprost
LATANOPROST		Gland
Show the other 100 applications
ApprovedApplicationMedicineSponsor
November 19, 2024ANDA216761 Erythromycin lactobionate
ERYTHROMYCIN LACTOBIONATE		Gland
October 4, 2024ANDA216911 Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE		Gland
October 3, 2024ANDA217648 Isoproterenol hydrochloride
ISOPROTERENOL HYDROCHLORIDE		Gland
October 3, 2024ANDA218630 Chlorothiazide
CHLOROTHIAZIDE SODIUM		Gland
August 12, 2024ANDA218993 Midazolam
MIDAZOLAM IN 0.9% SODIUM CHLORIDE		Gland
July 22, 2024ANDA218135 Procainamide hydrochloride
PROCAINAMIDE HYDROCHLORIDE		Gland
July 12, 2024ANDA218159 Travoprost ophthalmic solution
TRAVOPROST		Gland
May 6, 2024ANDA216199 Edaravone
EDARAVONE		Gland
May 3, 2024ANDA206644 Plerixafor
PLERIXAFOR		Gland
April 16, 2024ANDA218599 Tranexamic acid
TRANEXAMIC ACID		Gland
April 5, 2024ANDA218047 Eribulin mesylate
ERIBULIN MESYLATE		Gland
March 20, 2024ANDA218448 Diphenhydramine
DIPHENHYDRAMINE HYDROCHLORIDE		Gland
February 9, 2024ANDA216963 Vasopressin
VASOPRESSIN, VASOPRESSIN IN DEXTROSE 5%		Gland
January 3, 2024ANDA212605 Nelarabine
NELARABINE		Gland
December 26, 2023ANDA217553 Posaconazole
POSACONAZOLE		Gland
October 13, 2023ANDA214926 Fosphenytoin sodium
FOSPHENYTOIN SODIUM		Gland
August 18, 2023ANDA215623 Dihydroergotamine mesylate
DIHYDROERGOTAMINE MESYLATE		Gland
August 7, 2023ANDA217657 Carboprost tromethamine
CARBOPROST TROMETHAMINE		Gland
July 31, 2023ANDA217848 Argatroban
ARGATROBAN		Gland
July 6, 2023ANDA216791 Fomepizole
FOMEPIZOLE		Gland
June 22, 2023ANDA216839 Octreotide acetate
OCTREOTIDE ACETATE		Gland
June 13, 2023ANDA216807 Octreotide acetate
OCTREOTIDE ACETATE		Gland
April 12, 2023ANDA215583 Doxycycline
DOXYCYCLINE HYCLATE		Gland
March 30, 2023ANDA215509 Fluphenazine decanoate
FLUPHENAZINE DECANOATE		Gland
March 20, 2023ANDA216904 Desmopressin acetate
DESMOPRESSIN ACETATE		Gland
February 28, 2023ANDA215658 Ganirelix acetate
GANIRELIX ACETATE		Gland
January 24, 2023ANDA216809 Ketamine hydrochloride
KETAMINE HYDROCHLORIDE		Gland
November 22, 2022ANDA216648 Mitomycin
MITOMYCIN		Gland
November 16, 2022ANDA216922 Desmopressin acetate
DESMOPRESSIN ACETATE		Gland
September 26, 2022ANDA215657 Lincomycin
LINCOMYCIN HYDROCHLORIDE		Gland
September 19, 2022ANDA215520 Dorzolamide hydrochloride and timolol maleate
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE		Gland
September 19, 2022ANDA215628 Lacosamide
LACOSAMIDE		Gland
August 18, 2022ANDA210102 Ropivacaine hydrochloride
ROPIVACAINE HYDROCHLORIDE		Gland
July 12, 2022ANDA207320 Regadenoson
REGADENOSON		Gland
June 24, 2022ANDA214645 Timolol
TIMOLOL MALEATE		Gland
May 26, 2022ANDA216434 Bumetanide
BUMETANIDE		Gland
May 24, 2022ANDA215516 Cisatracurium besylate
CISATRACURIUM BESYLATE		Gland
May 18, 2022ANDA204400 Pantoprazole sodium
PANTOPRAZOLE SODIUM		Gland
May 3, 2022ANDA216249 Zinc sulfate
ZINC SULFATE		Gland
February 25, 2022ANDA216146 Ephedrine sulfate
EPHEDRINE SULFATE		Gland
January 27, 2022ANDA215660 Dorzolamide hydrochloride
DORZOLAMIDE HYDROCHLORIDE		Gland
January 26, 2022ANDA212363 Allopurinol
ALLOPURINOL SODIUM		Gland
October 20, 2021ANDA215687 Mitomycin
MITOMYCIN		Gland
October 7, 2021ANDA215059 Arsenic trioxide
ARSENIC TRIOXIDE		Gland
September 22, 2021ANDA214107 Prochlorperazine
PROCHLORPERAZINE EDISYLATE		Gland
August 4, 2021ANDA215654 Dexamethasone
DEXAMETHASONE SODIUM PHOSPHATE		Gland
July 1, 2021ANDA213510 Docetaxel
DOCETAXEL		Gland
May 18, 2021ANDA211189 Tobramycin
TOBRAMYCIN SULFATE		Gland
May 6, 2021ANDA214323 Norepinephrine bitartrate
NOREPINEPHRINE BITARTRATE		Gland
April 21, 2021ANDA213001 Foscarnet sodium
FOSCARNET SODIUM		Gland
April 8, 2021ANDA206888 Tirofiban
TIROFIBAN HYDROCHLORIDE		Gland
March 26, 2021ANDA212040 Ertapenem sodium
ERTAPENEM SODIUM		Gland
March 9, 2021ANDA212628 Tobramycin
TOBRAMYCIN		Gland
March 8, 2021ANDA214222 Thiotepa
THIOTEPA		Gland
February 11, 2021ANDA209621 Tobramycin
TOBRAMYCIN SULFATE		Gland
February 9, 2021ANDA209346 Tobramycin
TOBRAMYCIN SULFATE (PHARMACY BULK)		Gland
December 30, 2020ANDA206908 Levofloxacin
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER		Gland
November 23, 2020ANDA205539 Decitabine
DECITABINE		Gland
October 15, 2020ANDA214361 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE		Gland
September 24, 2020ANDA214390 Cyanocobalamin
CYANOCOBALAMIN		Gland
August 3, 2020ANDA212435 Metronidazole
METRONIDAZOLE IN PLASTIC CONTAINER		Gland
July 16, 2020ANDA213585 Milrinone lactate
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER		Gland
July 10, 2020ANDA213917 Magnesium sulfate heptahydrate
MAGNESIUM SULFATE IN PLASTIC CONTAINER		Gland
July 1, 2020ANDA213902 Furosemide
FUROSEMIDE		Gland
June 16, 2020ANDA214246 Succinylcholine
SUCCINYLCHOLINE CHLORIDE		Gland
June 5, 2020ANDA211920 Phenylephrine
PHENYLEPHRINE HYDROCHLORIDE		Gland
June 3, 2020ANDA209307 Dexmedetomidine
DEXMEDETOMIDINE HYDROCHLORIDE		Gland
April 22, 2020ANDA205540 Levofloxacin
LEVOFLOXACIN		Gland
April 1, 2020ANDA203349 Esomeprazole
ESOMEPRAZOLE SODIUM		Gland
March 31, 2020ANDA211099 Voriconazole
VORICONAZOLE		Gland
March 30, 2020ANDA208778 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE		Gland
March 17, 2020ANDA211029 Bromfenac
BROMFENAC SODIUM		Gland
February 25, 2020ANDA210092 Azelastine hydrochloride
AZELASTINE HYDROCHLORIDE		Gland
February 3, 2020ANDA211030 Calcitriol
CALCITRIOL		Gland
December 26, 2019ANDA211908 Ziprasidone
ZIPRASIDONE MESYLATE		Gland
December 23, 2019ANDA211937 Cytarabine
CYTARABINE		Gland
December 23, 2019ANDA211938 Cytarabine
CYTARABINE		Gland
November 18, 2019ANDA212993 Irinotecan hydrochloride
IRINOTECAN HYDROCHLORIDE		Gland
October 16, 2019ANDA212968 Neostigmine methylsulfate
NEOSTIGMINE METHYLSULFATE		Gland
September 30, 2019ANDA212612 Glycopyrrolate
GLYCOPYRROLATE		Gland
September 26, 2019ANDA210452 Doxercalciferol
DOXERCALCIFEROL		Gland
August 14, 2019ANDA208538 Esmolol hydrochloride
ESMOLOL HYDROCHLORIDE		Gland
August 8, 2019ANDA209578 Zoledronic acid
ZOLEDRONIC ACID		Gland
March 22, 2019ANDA210126 Bimatoprost
BIMATOPROST		Gland
October 31, 2018ANDA207831 Clofarabine
CLOFARABINE		Gland
October 26, 2018ANDA211504 Methocarbamol
METHOCARBAMOL		Gland
September 28, 2018ANDA078990 Enoxaparin sodium
ENOXAPARIN SODIUM (PRESERVATIVE FREE)		Gland
September 14, 2018ANDA210892 Levoleucovorin
LEVOLEUCOVORIN CALCIUM		Gland
June 29, 2018ANDA205749 Zoledronic acid
ZOLEDRONIC, ZOLEDRONIC ACID		Gland
April 4, 2018ANDA205656 Rocuronium bromide
ROCURONIUM BROMIDE		Gland
February 16, 2018ANDA206778 Adenosine
ADENOSINE		Gland
December 26, 2017ANDA210124 Fluorouracil
FLUOROURACIL		Gland
December 18, 2017ANDA206992 Mesna
MESNA		Gland
October 27, 2017ANDA210123 Fluorouracil
FLUOROURACIL		Gland
October 25, 2017ANDA206880 Levetiracetam
LEVETIRACETAM IN SODIUM CHLORIDE		Gland
September 29, 2017ANDA207092 Caspofungin acetate
CASPOFUNGIN ACETATE		Gland
September 29, 2017ANDA207384 Deferoxamine mesylate
DEFEROXAMINE MESYLATE		Gland
August 11, 2017ANDA209825 Doxorubicin hydrochloride
DOXORUBICIN HYDROCHLORIDE		Gland
May 23, 2017ANDA207385 Oxaliplatin
OXALIPLATIN		Gland
May 22, 2017ANDA205570 Argatroban
ARGATROBAN IN SODIUM CHLORIDE		Gland

Showing the 125 newest of 152 applications. Full lists: Drugs@FDA →

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

No recall of these products (by NDC code) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →